510(k) · Cleared
Recalled · 2008Reprocessed Endoscopic Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLW Electrode, Electrosurgical, Active, Urological, Reprocessed
Cleared on Feb 14, 2002 as substantially equivalent to K961702 (Karl Storz Endoskop GmbH, 1996) after a 184-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- Feb 14, 2002
- Review
- 184 days
- Class
- Class II
- Product code
- NLW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961702 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961702 Ksea Vaporization ElectrodesKarl Storz Endoskop GmbH · 1996
- This deviceK012685 Reprocessed Endoscopic ElectrodesSterilmed, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961702 | Ksea Vaporization Electrodes | Karl Storz Endoskop GmbH | 1996 | — |
| 0 (this device) | K012685 | Reprocessed Endoscopic Electrodes | Sterilmed, Inc. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961702 | Ksea Vaporization ElectrodesSummary page 6…lass II, 21 CFR 876.4300, and 21 CFR 884.4120 Panel 85 FAS, and HGI Reprocessed endoscopic electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) manufactured by Karl Storz Endoscopy, and the Vaportrode Vaporization Electrodes (K890328B) manufactured by Circon/ACMI. Reproc… | 1996 |
| Kept off the family tree | K890328 | FDA’s K890328 is Adult Resectoscope Our OCR of the scanned summary read K890328, FDA’s number for Adult Resectoscope (Circon Video). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vaportrode Vaporization Electrodes”. Kept off the family tree. Summary page 6…c electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) manufactured by Karl Storz Endoscopy, and the Vaportrode Vaporization Electrodes (K890328B) manufactured by Circon/ACMI. Reprocessed endoscopic electrodes are electrosurgical electrode devices that have a wide variety… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0573-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NLW devicesNLW Electrode, Electrosurgical, Active, Urological, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLW
FDA has decided no NLW device since 2007.
Median 510(k) review, days · NLW
Too few NLW 510(k)s in any year since 2007 to give a median.
Recalls per year · NLW
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLW
1in 2025
MAUDE reports naming product code NLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012685: Reprocessed Endoscopic Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026